Cleared Traditional

K120744 - XN CHECK BF

K120744 is an FDA 510(k) clearance for XN CHECK BF, manufactured by Streck. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K120744 · Streck · Hematology device
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Oct 2012
Decision
221d
Days
Class 2
Risk

K120744 is an FDA 510(k) clearance for the XN CHECK BF. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 221 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck devices

FDA 510(k) Submission Details - K120744

510(k) Number K120744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date October 19, 2012
Days to Decision 221 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 113d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K120744.
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